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等摩尔和偏态反应总前列腺特异性抗原检测与复合和游离前列腺特异性抗原检测及其比值在鉴别良性前列腺增生和前列腺癌中的临床性能评估。

Evaluation of the clinical performance of equimolar- and skewed-response total prostate-specific antigen assays versus complexed and free PSA assays and their ratios in discriminating between benign prostatic hyperplasia and prostate cancer.

作者信息

Wians Frank H, Cheli Carol D, Balko Jody A, Bruzek Debra J, Chan Daniel W, Sokoll Lori J

机构信息

Department of Pathology, The University of Texas Southwestern Medical Center, 193 Dallas, TX, USA.

出版信息

Clin Chim Acta. 2002 Dec;326(1-2):81-95. doi: 10.1016/s0009-8981(02)00250-4.

Abstract

BACKGROUND

Prostate-specific antigen (PSA) exists in human serum in two principal forms, free PSA (fPSA) and protein-complexed PSA, predominantly PSA-ACT (alpha(1)-antichymotrypsin). Equimolar response (EMR) total PSA (tPSA) immunoassays measure each of these forms equally while skewed-response (SKR) assays overestimate or underestimate the tPSA concentration. The advantages of EMR over SKR tPSA assays are controversial.

METHODS

We used five nonhuman serum-based samples each containing a different proportion of fSPA:PSA-ACT (0:100 to 100:0, %:%) and patients' serum samples from men with histologically confirmed benign prostatic hyperplasia (BPH) (n=94) or PCA (n=30) and a wide range of fPSA concentrations to investigate the molar response status of six tPSA assays. Receiver-operator characteristic (ROC) curve analysis was used to compare the discriminatory power of these assays in distinguishing men with BPH from those with PCA.

RESULTS

The Bayer Immuno-1 tPSA (BtPSA) assay demonstrated EMR characteristics and diagnostic accuracy similar to the Hybritech Tandem-E and Tandem-R tPSA assays. At 90% sensitivity, EMR tPSA assays had higher specificity than SKR tPSA assays.

CONCLUSIONS

The BtPSA assay is an EMR tPSA assay and EMR assays provide improved diagnostic specificity over SKR tPSA assays.

摘要

背景

前列腺特异性抗原(PSA)以两种主要形式存在于人体血清中,即游离PSA(fPSA)和与蛋白质结合的PSA,主要是PSA-ACT(α1抗糜蛋白酶)。等摩尔反应(EMR)总PSA(tPSA)免疫测定法对每种形式的测定是等同的,而偏倚反应(SKR)测定法则高估或低估tPSA浓度。EMR相对于SKR tPSA测定法的优势存在争议。

方法

我们使用了五个基于非人类血清的样本,每个样本含有不同比例的fSPA:PSA-ACT(0:100至100:0,%:%),以及来自组织学确诊为良性前列腺增生(BPH)(n = 94)或前列腺癌(PCA)(n = 30)且fPSA浓度范围广泛的男性患者的血清样本,以研究六种tPSA测定法的摩尔反应状态。采用受试者操作特征(ROC)曲线分析来比较这些测定法在区分BPH男性和PCA男性方面的鉴别能力。

结果

拜耳Immuno-1 tPSA(BtPSA)测定法显示出与Hybritech Tandem-E和Tandem-R tPSA测定法相似的EMR特征和诊断准确性。在90%灵敏度时,EMR tPSA测定法比SKR tPSA测定法具有更高的特异性。

结论

BtPSA测定法是一种EMR tPSA测定法,与SKR tPSA测定法相比,EMR测定法可提高诊断特异性。

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